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ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients

This study is developing a new way to predict how ovarian cancer patients will react to different chemotherapy drugs. Researchers will use a small sample of tumour cells, taken during standard surgery for advanced ovarian cancer. They will analyse these cells in the lab and then compare the results with how the patient's cancer actually responds to chemotherapy over several cycles. The goal is to build a computer program (an algorithm) that can use information from a patient's tumour to help doctors choose the most effective chemotherapy drugs for that individual. This could lead to more personalised and successful treatments in the future.

At a glance

Status
Recruiting
Sponsor
Pierian Biosciences
Enrolment target
100
Start
22 Nov 2023
Estimated completion
31 Jul 2027

What is this study about?

This study is working on a new way to help doctors choose the best chemotherapy for patients with advanced ovarian cancer. Instead of just following general guidelines that work for many people, the researchers want to find out what works best for each individual.

They plan to do this by taking a small sample of a patient's tumour, usually collected during their normal surgery. This sample is then tested in the lab to see how sensitive it is to different chemotherapy drugs. The researchers will also collect information about the patient's medical history and how their cancer responds to the chemotherapy they receive over time, up to about six cycles of treatment.

All this information – from the lab tests and the patient's actual treatment results – will be used to create a special computer program, called an algorithm. This program will be designed to predict which chemotherapy drugs are most likely to work for a patient based on their unique tumour. The main idea is to move towards more 'personalised' cancer treatment, where decisions are made based on the specific characteristics of each patient's cancer, rather than just general rules.

Key takeaways

  • This study helps develop personalised chemotherapy for ovarian cancer.
  • It uses a tumour sample from your standard surgery.
  • No new treatments or procedures are involved; it's an 'observational' study.
  • Information from your routine chemotherapy response is collected.
  • The goal is to create a 'prediction tool' for doctors.
  • Your involvement helps future patients, with no direct personal benefit.

Who may be eligible?

This study is open to women aged 18 or older who have been diagnosed with advanced ovarian cancer, or similar cancers of the lining of the belly (peritoneal carcinomatosis) or fallopian tubes.

You would be considered for the study if your diagnosis is new or if your cancer has come back. Importantly, you must have had a tumour sample taken during surgery or from fluid in your belly, which was then used for special lab tests before you started chemotherapy. You also need to have received at least three cycles of standard chemotherapy, using specific drugs listed by the researchers.

Unfortunately, you wouldn't be able to join if you haven't signed the consent form, have a different type of cancer, or didn't receive one of the specific chemotherapy treatments mentioned in the study. You also wouldn't be eligible if there weren't enough healthy tumour cells from your sample for the researchers to do their special lab tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman aged 18 or older?
  2. Do you have advanced ovarian cancer, or similar cancers?
  3. Did you have a tumour sample taken before starting chemotherapy?
  4. Have you started or received at least 3 cycles of standard chemotherapy for your cancer?
  5. Are you able to provide consent to take part?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't receive any new treatments or interventions directly related to the study. This is an 'observational' study, meaning researchers will observe and collect information from your existing medical care.

The main part of your participation involves allowing the researchers to use a sample of your tumour that was already taken during your standard surgery. They may also ask for a blood sample if possible. They will then collect information from your medical records, including your medical history, details about your cancer, and how you respond to your standard chemotherapy treatment for up to six cycles. There are no extra visits or assessments solely for the study; all information comes from your routine care. The total duration of your participation would involve the collection of data over your first six cycles of chemotherapy.

Potential risks and benefits

There are no direct medical risks from taking part in this study, as you won't receive any new medicines or procedures. The study only uses samples and information collected during your routine medical care. The main benefit is that you would be contributing to developing a new tool that could help future ovarian cancer patients receive more personalised and effective chemotherapy. While there are no direct benefits to you personally, your participation is very valuable for advancing cancer treatment. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Liverpool Women's NHS Foundation Trust
    Verified postcode
    Liverpool, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

The main goal is to create a tool that can predict which chemotherapy drugs will work best for individual ovarian cancer patients.

Will I receive new treatment through this study?

No, you will not receive any new treatments. The study observes how you respond to your standard chemotherapy treatment.

What kind of sample do they need?

They will use a small sample of your tumour that was already taken during your surgery. They might also ask for a blood sample.

How long will I be involved?

The study will collect information over your first six cycles of standard chemotherapy.

Will this study help me personally?

While it won't change your current treatment, your participation helps develop better, more personalised treatments for future patients with ovarian cancer.

How to find out more

Norman Purvis, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytot…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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